The present invention relates to methods and apparatus for delivering a surgical instrument to a treatment site within the body of a patient. More particularly, the present invention serves to simplify surgical procedures for treating a variety of ailments, by enabling accurate placement of surgical tools in areas not directly visible to a surgeon during a surgical procedure, while reducing or eliminating need for real-time imaging modalities to guide placement of those surgical tools. Hence, the present invention finds uses in, for example, interventional cardiology, interventional gastrology, interventional urology, interventional gynecology, endoscopy and laparoscopy, as well as other medical disciplines.
Minimally-invasive surgery has become increasingly important in recent years. Surgical treatments which once required major surgical opening of body cavities, merely to provide a surgeon with access to a desired treatment site, are now increasingly operable utilizing what is known in the art as “minimally-invasive” surgical procedures, wherein surgical tools are introduced into the body through small openings or through naturally occurring body conduits, and thence are navigated to a treatment site where they are used to perform a therapeutic act. Minimally-invasive procedures minimize trauma to the body resulting from the process of delivering surgical tools to a desired intervention site, and avoid much of the damage, at loci distant from the desired treatment site, which once accompanied most surgical procedures. Damage which once endangered patients, engendered complications, increased mortality, caused discomfort and suffering, caused extended hospitalization, and led to long and complex periods of recuperation, can now largely be avoided in many cases.
Minimally-invasive procedures are, however, by their nature, procedures wherein the surgeon has limited ability to directly observe what he is doing. Surgical tools are manipulated from outside the body, yet perform their work inside the body. Tools designed to navigate the length of body conduits, endoscopes for example, are typically provided with electronic cameras to enable the surgeon to observe the treatment site from within the body conduit.
Delivering a surgical tool to a treatment site not located within a body conduit, however, is more complex. Typically, external imaging modalities such as CT, Ultrasound, Fluoroscope, static x-rays, or MRI must be used to steer the surgical tool to its treatment site. Yet, use of such imaging modalities during a surgical procedure is often complex and in some cases quite difficult. Each known imaging modality presents certain disadvantages: extended periods of fluoroscopy, for example, require extended exposure to pathogenic x-rays. Use of MRI in the operating room, for another example, comports restrictions on the types of surgical equipment that can be utilized during MRI operation.
There is thus a widely recognized need for, and it would be highly advantageous to have, a device and method for delivering a surgical tool to a treatment site, or for confirming the position a surgical tool at a treatment site, which method and device obviate the need for, or reduce dependence on, use of imaging modalities during treatment.
Benign Prostate Hyperplasia, or “BPH”, which affects a large number of adult men, is a non-cancerous enlargement of the prostate. BPH frequently results in a gradual squeezing of the portion of the urethra that traverses the prostate, also known as the prostatic urethra. Squeezing of the prostatic urethra causes patients to experience a frequent urge to urinate because of incomplete emptying of the bladder, and a burning sensation or similar discomfort during urination. The obstruction of urinary flow can also lead to a general lack of control over urination, including difficulty initiating urination when desired, as well as difficulty in preventing urinary flow because of the residual volume of urine in the bladder, a condition known as urinary incontinence. Left untreated, the obstruction caused by BPH can lead to acute urinary retention (complete inability to urinate), serious urinary tract infections and permanent bladder and kidney damage.
Most males will eventually suffer from BPH. The incidence of BPH for men in their fifties is approximately 50% and rises to approximately 80% by the age of 80. The general aging of the United States population, as well as increasing life expectancies, is anticipated to contribute to the continued growth in the number of BPH sufferers.
Patients diagnosed with BPH generally have several options for treatment: watchful waiting, drug therapy, surgical intervention, including transurethral resection of the prostate (TURP), laser assisted prostatectomy and new less invasive thermal therapies.
Currently, of the patients suffering from BPH, the number of patients who are actually treated by surgical approaches is approximately 2% to 3%. Treatment is generally reserved for patients with intolerable symptoms or those with significant potential symptoms if treatment is withheld. A large number of the BPH patients delay discussing their symptoms or elect “watchful waiting” to see if the condition remains tolerable.
Thus, there is thus a widely recognized need for, and it would be highly advantageous to have, a device and method simplifying therapeutic intervention for relief of BPH, thereby making the procedure more attractive to potential patients and less complex and expensive for health providers, potentially resulting in a substantial increase in the number of BPH suffers who elect to receive interventional therapy.